Koios DS 用于乳腺
K号: K190442 · 2019-07-03
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器械摘要
Koios DS for Breast is the device name listed in this FDA 510(k) record. The listed applicant is Koios Medical, Inc.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K190442. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Koios DS for Breast?
Koios DS for Breast is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Koios Medical, Inc.. The 510(k) number is K190442.
When did Koios DS for Breast receive FDA 510(k) clearance?
Koios DS for Breast received FDA 510(k) clearance on 2019-07-03, under 510(k) number K190442.
Who is the listed applicant for Koios DS for Breast?
The FDA 510(k) record lists Koios Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Koios DS for Breast?
The FDA product code for Koios DS for Breast is POK.
相关临床试验
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列明Koios Medical, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：POK）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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